SUMMARY

• SunRISe-3 (NCT05714202) is an ongoing, phase 3, randomized, open-label, multicenter study comparing event-free survival (EFS) in patients with Bacillus Calmette-Guérin (BCG)naïve high-risk non-muscle-invasive bladder cancer (HR-NMIBC) receiving TAR-200 (JNJ-17000139) plus cetrelimab or TAR-200 alone vs intravesical BCG. The results of this study have not been published.^1-3

BACKGROUND

• TAR-200 (JNJ-17000139) is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.^4-7   
• TAR-200 is inserted intravesically via a urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: TAR-200 Intravesical System). Removal of TAR-200 can be achieved using grasping forceps and flexible cystoscopy.^5,7

CLINICAL DATA

SunRISe-3 Study

Study Design/Methods

• Phase 3, ongoing, randomized, open-label, multicenter study designed to compare EFS in patients with BCG-naïve HR-NMIBC receiving TAR-200 plus cetrelimab (group A) or TAR200 alone (group C) vs intravesical BCG (group B).^1-3
• Primary disease assessments will be conducted at screening and during the treatment phases (first 2 years and an optional third year). The assessments will include²:
  • Cystoscopy and urine cytology at weeks 12, 24, 36, and 48.
  • Transurethral resection of bladder tumor/bladder biopsy mandatorily for carcinoma in situ (CIS) at week 24 and as clinically indicated for other cases.
  • Computed tomography/magnetic resonance imaging urogram every 24 weeks for CIS patients and every 48 weeks for papillary patients during the treatment phase.
• The study design has been detailed in Figure: SunRISe-3 Study Design.

• Enrollment is planned for approximately 1050 patients.^1,3

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 23 January 2025.